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U.S. Department of Health and Human Services

Class 2 Device Recall Catalyst System

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  Class 2 Device Recall Catalyst System see related information
Date Initiated by Firm August 06, 2020
Create Date July 14, 2021
Recall Status1 Terminated 3 on April 15, 2022
Recall Number Z-2075-2021
Recall Event ID 88084
510(K)Number K113276  
Product Classification Accelerator, linear, medical - Product Code IYE
Product PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003 version 6.1.1 and 6.1.0
Code Information Catalyst: SP-002, Software (part number): PA-003 version 6.1.1 and 6.1.0
Recalling Firm/
Manufacturer		 C-RAD POSITIONING AB
Bredgrand 18
Uppsala Sweden
For Additional Information Contact Tim Thurn
4618666930
Manufacturer Reason
for Recall		 PC Application Software c4D not changing Site upon synchronization during the Setup workflow step
FDA Determined
Cause 2		 Component change control
Action On August 11, 2020, an e-mail letter containing PA-003-200806-001-01, c4D not changing Site upon synchronization during the Setup workflow step (attached) has been sent personally to our contact persons at the affected sites. In a second step C-RAD upgraded the software at all affected sites to bring back the system to the originally intended state..
Quantity in Commerce 7
Distribution US Nationwide distribution in the states of IL, KY, MO and WA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IYE and Original Applicant = C-RAD POSITIONING AB
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